Abbott Senior Specialist, Packaging and Labeling in Plymouth, Minnesota
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Creates and modifies labeling for product labels, cartons and other related materials ensuring that they meet all medical, legal and regulatory requirements for medical devices following the established design format, labeling style guidelines and branding guidelines.
Functional/core team representative on a cross-functional team in taking labeling content and translating it into functional label layouts utilizing labeling software. Provides direction on label content and process requirements to cross-functional members. May lead strategic labeling sub-teams (e.g. acquisitions, manufacturing transfers, global labeling requirement changes, etc.). May work on both commercialized and new product labeling projects.
Works cross-functionally to drive consistency across labeling project materials, designs and application of requirements to meet project objectives.
Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing and production techniques.
Creates and manages labeling change requests within the document management system.
Bachelor’s degree in Communications (Graphic Design, Technical Writing, or Mass Communications), Regulatory, or a Technical Discipline (Mathematics, Science, or Engineering).
Minimum of 7 years’ experience working with product labeling, design dossiers, quality systems and/or regulatory labeling.
Experience developing artwork and graphics for FDA regulated medical products and creation and management of change requests in an electronic environment.
Knowledge required in operating and supporting database driven production labeling software such as EasyLabel, PrintWare, enLabel, BarTender, NiceLabel or other related software.
Capability to utilize computer-aided design equipment and/or graphic tools such as, CAD, Adobe Illustrator/Photoshop and similar software.
Experience initiating electronic change requests and completing associated implementation tasks utilizing PLM systems such as WindChill, Agile or other related software.
Familiarity of enterprise level ERP systems, such as SAP, Oracle, JDEdwards or similar software.
Ability to schedule and organize multiple projects.
Ability to communicate effectively with internal and external customers and team members.
Thorough knowledge of FDA, GMP, and ISO guidelines.
Requires ability to be innovative, resourceful, and work with minimal direction.
Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
PMP and/or Six Sigma Certifications, a plus.
Manages multiple concurrent deadlines.
May identify and lead the implementation of packaging/labeling process improvement projects.
Provides detailed project management (schedule, deadlines) for projects assigned. Reports on status. May assist in assigning tasks, providing direction, and developing schedules/deadlines to Specialist I, Specialist II team members.
Maintains knowledge of new developments in packaging and labeling technologies.
Works on projects that are large in scope/ high profile.
Provides mentoring and training to Label Designer I/II team members and contractors.
Leads or works on significant/critical department improvement projects and may lead or support internal or external strategic initiatives (e.g. UDI).
May participate in industry-level committees.
Owns and develops department level procedures and work instructions.
Supports all initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org